Neoadjuvant Immunoradiotherapy: Head & Neck Cancer (NIRT-HNC)

Who is this study for? Adult patients with Head and Neck Squamous Cell Carcinoma
Status: Active_not_recruiting
Location: See location...
Intervention Type: Procedure, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with squamous cell carcinoma of the head and neck region, (including mucosal,cutaneous, or nodal) who are planned for surgical resection and in the opinion of the investigator are able to safely undergo neoadjuvant anti-PD-1 and radiation. In addition, the following are eligible (but will not contribute toward total accrual): non-surgical cases that are planned for palliative RT or that refuse or are unfit for definitive concurrent chemotherapy.

• HPV status as determined by p16 immunostain

• Cohort 3: HPV-positive patients only

• Cohort 4: HPV-negative patients only

• Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document. Patients with history of psychiatric illness must be judged by the investigator as able to understand the investigational nature and risks associated with the therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status deemed suitable by investigator for study requirements.

• Laboratory values (most recent), must be within 6 weeks of week 0 on study:

‣ WBC ≥ 2000/uL, ANC ≥ 1000/uL

⁃ Hgb \> 8g/dL (patients may be transfused to reach this level)

⁃ Platelets \> 50,000 cells/mm3

⁃ Creatinine ≤ 3 x ULN

⁃ AST/ALT ≤ 5 x ULN for subjects without liver metastasis; or ≤ 8 x ULN for subjects with liver metastasis, \[per investigator brochure\]

⁃ Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)

⁃ Negative pregnancy test (bHCG urine or serum, women of childbearing potential only)

• Women of child-bearing potential (WOCBP) must agree to follow adequate contraceptive practices to avoid pregnancy for the duration of treatment with nivolumab plus 5 half-lives of nivolumab (75 days) plus 30 days (duration of ovulatory cycle) for a total of 105 days post-treatment completion.

• Males who are sexually active with WOCBP must agree to follow adequate contraceptive practices to avoid pregnancy for the duration of treatment with study drug (s) plus 5 half lives of the study drug (75 days) plus 90 days (duration of sperm turnover) for a total of 165 days post-treatment completion.

Locations
United States
Oregon
Providence Portland Medical Center
Portland
Time Frame
Start Date: 2018-01-15
Completion Date: 2026-12
Participants
Target number of participants: 22
Treatments
Experimental: Treatment Cohort 1
Nivolumab administration (3 doses) and radiation (5 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Experimental: Treatment Cohort 2
Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Experimental: Treatment Cohort 3
Radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Experimental: Treatment Cohort 4
Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Sponsors
Leads: Providence Health & Services
Collaborators: Providence Cancer Center, Earle A. Chiles Research Institute

This content was sourced from clinicaltrials.gov